kaitoh atherectomy fih

Conditions: Peripheral Arterial Disease

Summary: this is a prospective, multi-center and single-arm clinical study to assess the initial safety and effectiveness of the kaitoh atherectomy system for the treatment of de novo and/or restenotic lesion(s) in the peripheral arteries.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * rutherford classification: 3-5 in target limb; rutherford classification 3 subjects may be enrolled but will be capped to a limit of 20% of the total enrollment (no more than two rutherford class 3 subjects may be enrolled into the study). * able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months) * able to comply with antiplatelet therapy as required * reference vessel diameter is ≥2.0 mm and ≤4.0 mm * target lesion length is ≤150 mm * de novo or restenotic target lesion(s) (except for in-stent restenotic lesion) with stenosis ≥70%, by visual estimation, in a single limb in a single native vessel * inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as visually confirmed by angiography. note: successful inflow artery treatment is allowed during the index procedure. successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤50% without major vascular complications (absence of flow limiting dissection, embolic event) * guidewire has successfully crossed the target lesion(s) within the true lumen exclusion criteria: * females who are pregnant or lactating * pre-existing illness with life expectancy \<1 year * known or suspected systemic infection * significant gastrointestinal bleeding or any coagulopathy that would preclude the use of anti-platelet therapy * subjects with a diagnosis of osteomyelitis and are currently on iv antibiotic therapy * endovascular or surgical procedure performed on the target lesion within 3 months of the index procedure * subjects who in the opinion of the investigator have underlying kidney disease and may be at risk for contrast-induced acute kidney injury (aki) * subjects who in the opinion of the investigator have uncontrolled diabetes * allergic to iodine/radiopaque contrast that in the opinion of the investigator cannot be adequately pre-treated * history of coronary artery bypass graft (cabg), unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 90 days * subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb * allergic to any of the components of the atherectomy device system * intraprocedural complications prior to use of the investigational device * subjects with a positive covid-19 test within the last 60 days and/or is symptomatic, at the investigator's discretion * subject with other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre - and post-treatment * presence of flow-limiting stenosis (\>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (\<50% residual stenosis without flow limiting dissection) before the study intervention/prior to the point of enrollment * no obvious angiographic evidence of flow to the foot following inflow treatment * co-existing aneurysmal disease requiring treatment * presence of vessel dissection at the target lesion requiring stent placement * clinical/angiographic evidence of distal embolization or acute thrombus * severe calcification that is measured \>10mm in length and circumferential * prior stent placement in the target lesion